SAN DIEGO--(BUSINESS WIRE)--Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery
and diabetes technology company, today announced that it intends to use
its remote software update tool, the Tandem Device Updater, to resolve a
Control-IQ technology software anomaly identified during the ongoing
DCLP3 phase of the International Diabetes Closed Loop (IDCL) clinical
trial. The Company anticipates that the software update will be
available to study sites before the end of March.

“A primary reason for a larger pivotal clinical trial is to identify and
resolve infrequent anomalies like this that may not appear in smaller
studies. Being able to address this now helps us to offer a more robust
product for our customers at launch,” said John Sheridan, president and
chief executive officer. “Our ability to quickly develop and provide
trial participants a remote software update is another example of the
revolutionary power of our Tandem Device Updater, and our Company’s
nimble research and development capabilities. We continue to prepare for
the launch of our Control-IQ technology in the second half of this year,
subject to successful completion of the study and FDA review.”

The anomaly relates to how the t:slim X2 insulin pump with Control-IQ
technology handles continuous glucose monitoring (CGM) data under
specific conditions, which could then impact the system’s prediction of
future blood glucose values and automated insulin delivery.
Manifestations of this anomaly are rare and have not resulted in any
reportable adverse events; however, due to an increased risk of
hypoglycemia, use of the Control-IQ software feature in the IDCL study
will be temporarily suspended until the software update is available.

The Company is currently in discussions with the IDCL study
investigators to evaluate any impact of the software update to the
clinical or regulatory strategy for the t:slim X2 insulin pump with
Control-IQ technology. Currently, approximately 120 out of 168 trial
participants have completed the 6-month DCLP3 study. Individuals who
complete the 6-month study period are then enrolled in a 3-month
extension to the primary study. The Company has notified other clinical
trial sponsors using Control-IQ technology of the anomaly and that a
software update will be made available. The DCLP5 study, which is the
pediatric arm of the IDCL study, will commence following availability of
the updated software.

About Tandem Diabetes Care, Inc.

Tandem Diabetes Care, Inc. (www.tandemdiabetes.com)
is a medical device company dedicated to improving the lives of people
with diabetes through relentless innovation and revolutionary customer
experience. The Company takes an innovative, user-centric approach to
the design, development and commercialization of products for people
with diabetes who use insulin. Tandem’s flagship product, the t:slim X2™
insulin pump, is capable of remote software updates using a personal
computer and features integrated continuous glucose monitoring. Tandem
is based in San Diego, California.

Tandem Diabetes Care is a registered trademark and t:slim X2 and
Control-IQ are trademarks of Tandem Diabetes Care, Inc.

Forward Looking Statement

This press release contains “forward-looking statements” within the
meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended, that
concern matters that involve risks and uncertainties that could cause
actual results to differ materially from those anticipated or projected
in the forward-looking statements. These forward-looking statements
relate to, among other things, the Company’s plan to use the Tandem
Device Updater to resolve the Control-IQ technology software anomaly
during an ongoing clinical trial, including the Company’s ability to
resolve the software anomaly and the timing of the anticipated software
update; whether the data from the IDCL trial will be adequate to support
a future regulatory filing; the Company’s ability to obtain regulatory
approval for the t:slim X2 with Control-IQ technology, and the timing of
the anticipated commercial launch of the t:slim X2 with Control-IQ
technology. These statements are subject to numerous risks and
uncertainties, including: the Company may be unable to develop and
deploy the software update when anticipated or at all; the FDA may not
agree with the plan to temporarily suspend and then resume the use of
Control-IQ technology as part of the DCLP3 study; the results of the
Company’s ongoing clinical studies may not demonstrate the safety and
effectiveness of the Company’s products under development or be
sufficient to support a future regulatory filing; the Company may not be
able to commence the DCLP5 study in a pediatric population when
anticipated; as well as the other risks and uncertainties identified in
the Company’s most recent Annual Report on Form 10-K and its other
filings with the Securities and Exchange Commission. Readers are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date of this release. The Company
undertakes no obligation to update or review any forward-looking
statement in this press release because of new information, future
events or other factors.